Inspections, Compliance, Enforcement, and Criminal Investigations

Obstetrics Gynecology, Ltd 1/10/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Southwest Regional Office
4040 North Central Expressway
Suite 900
Dallas, Texas 75204 

WARNING LETTER

January 10, 2014
 

UPS NEXT DAY AIR

Re: MQSA Inspection ID # 224520                                                                                                      2014-SWR-01
FEI# 3003353805
 

Ruston Pierce, M.D.
Physician/Owner
Obstetrics-Gynecology Ltd.
1702 West 42nd Avenue
Pine Bluff, AR 71603
 

Dear Dr. Pierce,
 

On September 23, 2013, a representative of the State of Arkansas, acting on behalf of the Food and Drug Administration (FDA) conducted an inspection at your facility which revealed a serious problem involving the conduct of mammography. Under the Mammography Quality Standards Act of 1992 ("MQSA") which is codified in Section 263b of Title 42 of the United States Code (USC), you must meet specific requirements to practice mammography. These requirements help protect the health of women by assuring that a facility can perform quality mammography.

The problems identified during this inspection constitute a violation of the MQSA at your facility. These violations were noted on the MQSA Facility Inspection Report and the document "Important Information about Your MQSA Inspection" that the inspector mailed to your facility on September 27, 2013. The violations are again identified below:

Level 1: Processor QC records in the Month of 07/2013 were missing for at least 30% of operating days, for (b)(4) processor at site Obstetrics-Gynecology Ltd. [ See 21 CFR 900.12 (e)(1)].

Level 1: Processor QC records were missing at least 5 consecutive days for (b)(4) processor at site Obstetrics-Gynecology Ltd. [See 21 CFR 900.12(e)(1)] .

Level 1: Phantom QC records were missing for at least 4 weeks for unit (b)(4) Mill at site Obstetrics-Gynecology Ltd. [See 21 CFR 900.12(e)(2)].

Level 2: Medical audit and outcome analysis was not done separately for each individual physician at site Obstetrics-Gynecology Ltd . [See 21 CFR 900.12 (f)(1)].

On October 2, 2013, your facility responded by letter to the noncompliances found during this inspection as referenced in this Warning Letter.  Based on your response, your facility has implemented a correction that addresses the documented noncompliances.

Because these violations may be indicative of serious underlying problems that could compromise the quality of mammography at your facility, FDA may take additional actions, including, but not limited to, the following: 

• requiring your facility to undergo an Additional Mammography Review
• placing your facility under a Directed Plan of Correction
• charging your facility for the cost of on-site monitoring
• requiring your facility to notify patients who received mammograms at your facility, and their referring physicians, of the deficiencies, the potential harm resulting from such deficiencies, appropriate remedial measures, and other relevant information
• seeking civil money penalties up to $10,000 for each failure to substantially comply with, or each day of failure to substantially comply with, MQSA standards
• seeking to suspend or revoke your facility's FDA certificate
• seeking a court injunction against your facility
 

See 42 USC 263b(h)-(j) and 21 CFR 900.12(j).

FDA may need to perform a Compliance Follow-up Inspection to determine that each problem at your facility has been corrected.

Finally, you should understand that there are many requirements pertaining to mammography. This letter pertains only to violations related to the recent inspection of your facility and does not necessarily address other obligations you have under the law. You may obtain general information about all of FDA's requirements for mammography facilities by contacting the Mammography Quality Assurance Program, Food and Drug Administration, P.O. Box 6057, Columbia, MD 21045-6057 (1-800-838-7715) or through the Internet at http://www.fda.gov/cdrh/mammography/index.html.

If you have additional or more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Deborah M. McGee, M.S., Southwest Regional Compliance Officer, by telephoning (214) 253-4935.
 

Sincerely yours,
/S/
Dennis E. Baker
Regional Food and Drug Director
Southwest Regional Office
 

cc:
Bernard R. Bevill, Section Chief
Arkansas Department of Health
Radiation Control Section
4815 W. Markham St., Slot H-30
Little Rock, AR 72205-3867
 

Page Last Updated: 01/27/2014
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